Clearly, one of the responses to the economic and financial turmoil of the past several years has been a significant increase in legislative and regulatory oversight of business. The following offers guidance in key areas where business and regulation intersect with respect to transactions, risk prevention/avoidance, and the defense of conduct challenged by the government or private parties. We also discuss the increasing need to integrate litigation and regulatory strategies into many of the complex and highly publicized situations that businesses are facing more frequently. (See "Global Litigation.")

Communications: FCC Approves Controversial ‘Network Neutrality’ Rules

After a contentious, year-long proceeding that split the agency along political and ideological fault lines, the Federal Communications Commission (FCC) voted 3-2 on December 21, 2010, to adopt so-called “network neutrality” rules to regulate the provision of broadband Internet access to consumers. The party-line vote, over strenuous dissents from the FCC’s two Republican commissioners, will for the first time implement binding rules to preclude Internet service providers (ISPs) from blocking consumers’ access to lawful websites or applications and prevent ISPs from discriminating against disfavored content.

The new rules specifically will (i) restrict ISPs from blocking consumers’ access to lawful content, applications and services on the Internet; (ii) bar fixed (wired) broadband providers from engaging in unreasonable discrimination in transmitting lawful network traffic; and (iii) require that ISPs provide consumers with clear and transparent information about the way that they manage broadband networks. Wireless broadband providers must abide by the no-blocking and transparency rules, but will have additional flexibility to prioritize traffic on their networks (except that they cannot favor co-owned traffic). All ISPs will be permitted to engage in “reasonable network management” — practices that are “appropriate and tailored to achiev[e] a legitimate network management purpose, taking into account the particular network architecture and technology” of the broadband service.

In response to the concerns of content creators and intellectual property owners about the large and growing threat of online piracy, the FCC indicated in its order that its rules would not prevent ISPs from making “reasonable efforts” to “address copyright infringement or other unlawful activity.”

While the new rules will apply to the public Internet, the FCC also recognized that businesses are experimenting with new and innovative delivery models that distribute content parallel to the public Internet using the same network architecture. These so-called “specialized services,” including types of voice-over-Internet Protocol (VOIP) and IP-video offerings, are too nascent to warrant regulation at this time. The FCC cautioned, however, that it will closely monitor the development of these services and will consider future regulation if “specialized services” threaten to impede the development of the public Internet.

The FCC’s order was an attempt at compromise, with the agency taking a measured approach to its authority to exercise jurisdiction over the Internet. Proponents of the rules had urged the FCC to rely on its more expansive statutory powers to regulate telecommunications companies, but in anticipation of legal challenges, the FCC chose a narrower approach in an attempt to draw broader support. Ironically, this decision has led to criticism even from those quarters where support for network neutrality regulations was strongest — including those who feel that the new rules do not go far enough — while at the same time has done little to decrease the likelihood of legal challenges. Indeed, the two Republican commissioners’ dissents contain lengthy and detailed analyses of what they perceive to be the legal infirmities of the FCC’s chosen approach. Various members of Congress also have threatened to introduce legislation in 2011 to unwind the new rules, or to at least preclude the agency from expending any funds to enforce them.

As expected, the Republican Caucus in the House of Representatives designated Darrell Issa (R-CA) as chairman of the Oversight and Government Reform Committee for the 112th Congress. Rep. Issa already has made several statements concerning his plans for the committee, telling Politico magazine on November 8, 2010, “I want seven hearings a week, times 40 weeks.” As many as 80 investigative staff are expected to be on board once the Republican-controlled committee is operating at full force.

Rep. Issa has stated that he expects at least one of his seven subcommittees will hold a hearing every week, a plan that appears to be fully endorsed by his party’s leadership. After the election, Majority Leader-elect Eric Cantor (R-VA) issued a report to his Republican colleagues entitled “Delivering on Our Commitment,” which advises the new majority party “to highlight one major oversight hearing each week that plays into our overall focus on job creation and reducing spending.”

Among the topics long on Rep. Issa’s stated agenda are health care reform legislation, the TARP program, stimulus grants, Fannie Mae and Freddie Mac, Medicare and the U.S. Postal Service. Recently, he added airport security and WikiLeaks to the list. Private companies can anticipate becoming enmeshed in these investigations, especially those focused on alleged misfeasance by the Obama administration. These include companies affected by the new health care act; businesses impacted by the Dodd-Frank reforms; financial institutions involved in all aspects of the housing market, mortgages and foreclosures; companies that received or administered TARP funds or assets; businesses that benefited from federal stimulus funds; and defense and IT firms that contract with the government. Regarding how his committee and subcommittees will proceed, Rep. Issa told “Fox News Sunday’s” Chris Wallace on November 7, 2010, “We’re going to look for the person most knowledgeable of our problem and have them before our committee. And in many cases we’re going to do it outside the public glare through depositions, with Republicans and Democrats both sitting there.”

Other House committees appear less motivated to launch major corporate investigations. Indeed, at least one member of the House, Rep. Fred Upton (R-MI), indicated he had the opposite in mind. When selected as chairman of the House Energy and Commerce Committee, Rep. Upton announced that the “two-year assault on the health, energy and telecommunications sectors is now over.” While such oversight activities may not target companies or industry sectors directly (as did House Democrats examining the financial crisis or Gulf oil spill), companies may become entangled in matters in which congressional panels are seeking to highlight deficiencies in agency, regulatory or enforcement action.

At the same time, Democrats remain in charge of the Senate’s investigatory apparatus. Senate leadership has been preoccupied with attempting to get legislative initiatives passed in the lame-duck session, and leaders of the key Senate investigating committees have said little about their plans in the new Congress. If past is prologue, however, areas of focus are likely to include the housing foreclosure process, WikiLeaks and other Internet security and privacy issues, the operations of investment banks, consumer fraud and possibly even the safety of NFL football.

Companies can be caught off guard when a congressional investigation arises with little warning. If not properly handled, these inquiries can do substantial damage to a business’s reputation and stock price and to the credibility of its top executives, as was demonstrated in myriad hearings involving the Gulf oil spill in 2010. Once Congress begins such an investigation, the legal grounds to prevent it from proceeding are few. As the Supreme Court has stated, “[t]he scope of [Congress’] power of inquiry … is as penetrating and far-reaching as the potential power to enact and appropriate under the Constitution.”1 It extends to any subject that is, has been or might be the subject of legislation.2 Short of a situation in which Congress has violated an individual’s constitutional rights, courts rarely intervene in congressional inquiries. A company that becomes the focus of a congressional inquiry is therefore well advised to retain counsel with extensive experience in handling crisis situations and dealing with the media, and who is knowledgeable about the impact such investigations can have on any parallel criminal and civil proceedings.3

Energy: Regulations Affecting the Electric Power Industry

As prospects dim for significant new legislation affecting the energy industry, attention in 2011 will turn to new policies proposed by executive branch agencies, the impact of which is expected to be significant. What follows is a summary of key reforms likely to be proposed or adopted by the Federal Energy Regulatory Commission (FERC), the Commodity Futures Trading Commission (CFTC) and the Environmental Protection Agency (EPA).

FERC Policy Initiatives

Transmission Cost Allocation. The steady increase in renewable resources being connected to the grid has created sharp debates over who should pay for the associated transmission facilities necessary to deliver it to load. In June 2010, FERC proposed to require each region to conform its allocation policies to a set of new principles articulated by FERC. These principles appear to envision a broader allocation of costs than occurs in certain regions today, by proposing to eliminate the so-called “participant funding” approach to cost allocation. The comment period is now complete on FERC’s proposal and a final rule is expected in mid-2011. Equally important, FERC is likely to rule in 2011 on a controversial cost allocation method for the PJM region (which stretches from New Jersey to Illinois) that was struck down by the U.S. Court of Appeals for the Seventh Circuit. In that case, FERC will reconsider its earlier decision to spread the cost of new, extra-high voltage 500kV facilities across the entire region. FERC collected new evidence on whether such facilities produce benefits to the entire region or, alternatively, mostly for customers in the eastern portion of PJM.

Variable Energy Resources. In addition to transmission cost allocation issues, renewable resources also have created operational challenges for grid operators. In November 2010, FERC proposed a new rule to address certain of these challenges and their cost implications. The proposed rule would (i) require utilities to offer intra-hour scheduling to allow for more accurate scheduling of variable resources, (ii) require variable resources to provide better meteorological and operational data to improve the forecasting capability of system operators, and (iii) allow public utilities to charge for generation regulation and frequency response service. FERC will be receiving comments on these proposals in the next few months and is expected to issue a final rule sometime in 2011.

Demand Response. Another challenging policy issue is the appropriate pricing for demand response offered into organized electricity markets. In March 2010, FERC proposed that demand responders (i.e., energy consumers who have agreed to decrease their consumption when power is scarce) be compensated at the same wholesale price as power plants receive for the energy they generate. This proposal has proven controversial, with economists and industry groups arguing that it would be efficient only if demand responders were first required to buy the power from their local utility at the retail price before selling it back at wholesale or, alternatively, if they received only the excess of the higher wholesale price over the lower retail price. Other groups contend that the proposal could be modified (e.g., through a “net benefits” test) to address these concerns. In total, more than 200 comments were filed in response to the proposed rule. A final rule is expected in 2011.

Smart Grid. The “smart grid” encompasses a variety of technological advances, supported by policy reforms, that allow grid operators to increase the reliability and efficiency of the electric grid. One element of this reform agenda involves FERC. The Energy Independence and Security Act of 2007 required the National Institute of Standards and Technology to (i) coordinate efforts to achieve interoperability of Smart Grid devices and systems and (ii) then feed recommendations to FERC. The statute then directed that FERC adopt standards and protocols “necessary to insure smart-grid functionality and interoperability” in electric transmission and wholesale markets. In a Policy Statement issued in July 2009, FERC said it would adopt standards applicable to all power facilities and devices with Smart Grid features — explicitly including facilities/devices at the local distribution level and those directly used by retail customers if necessary to ensure interstate functionality and interoperability. FERC added that it may make compliance with its Smart Grid standards and protocols a mandatory condition for rate recovery of FERC-jurisdictional Smart Grid costs. After a long review process, on October 6, 2010, NIST sent five groups of new Smart Grids standards to FERC. The next day, FERC created a new rulemaking docket (RM11-2-000) and stated that it would issue a notice of proposed rulemaking “in the near future.”

CFTC Proposals To Implement Dodd-Frank

In Title VII of Dodd-Frank, Congress defines the term “swap” very broadly and directs the CFTC to refine the scope of which agreements, contracts or transactions are to be considered swaps (see “Financial Regulation/Derivatives”). At least until the CFTC provides further clarity through interpretation or rule, we will not know the full breadth of energy agreements, contracts or transactions that will be regulated as swaps. Examples of energy contracts, transactions or agreements that could be swaps include:

Financial Transmission Rights contracts;

Contracts for Differences in energy or ancillary products (e.g., capacity); and

any transactions in an organized market’s day-ahead market that are not intended to be settled physically.

The Dodd-Frank regulatory consequences for swaps are serious and comprehensive. Generally speaking, Dodd-Frank creates two categories of persons whose extensive use of swaps requires regulation: swap dealers and major swap participants, both of which will be subject to extensive regulatory requirements for capital, margin, business conduct, recordkeeping and daily reporting.

Dodd-Frank also divides swaps into two categories: swaps the CFTC determines must be exchange-traded and cleared (“cleared swaps”) and swaps that are not required to be cleared (“uncleared swaps”). Swap dealers and major swap participants will be required to trade cleared swaps on exchanges and submit them for clearing. The only exception to this requirement will be for swaps entered into with qualified “commercial end-users,” who will be allowed to elect whether to clear or exchange-trade those swaps held to hedge or mitigate “commercial risk.” Uncleared swaps will be subject to capital, margin, recordkeeping, reporting and business conduct requirements (see below).

Swap Dealers

The CFTC is establishing rules to determine who must be regulated as a swap dealer or major swap participant. Under the CFTC’s proposal, a person would generally be a swap dealer if that person:

holds oneself out as a dealer in swaps;

makes a market in swaps;

regularly enters into swaps with counterparties as an ordinary course of business for one’s own account; or

engages in activity causing oneself to be commonly known in the trade as a dealer or market maker in swaps.

Major Swap Participants

A nonswap dealer would be a major swap participant if that person’s swap positions equal or exceed the CFTC’s proposed thresholds:

$3 billion of current exposure in rate swaps (swaps based primarily on reference rates);

$6 billion of combined current exposure and potential future exposure in rate swaps;

$1 billion of current exposure or $2 billion of combined current exposure and potential future exposure in:

credit swaps (swaps based primarily on indebtedness);

equity swaps (swaps based primarily on equity securities); or

other commodity swaps (swaps that are not rate swaps, credit swaps or equity swaps — this would likely include most, and maybe all, energy swaps); or

$5 billion of current exposure or $8 billion of combined current exposure and potential future exposure in all swaps collectively.

Commercial End-User Exemptions

Businesses that use swaps may be exempt from (i) the major swap participant definition and (ii) the exchange-trading and clearing mandate for “cleared swaps” to the extent the business enters into swaps to hedge or mitigate commercial risk. The CFTC’s recent proposals would define when a swap would be considered to hedge or mitigate commercial risk as when a swap:

is economically appropriate to the reduction of certain risk in the conduct and management of a commercial enterprise;

would qualify as bona fide hedging for position-limit purposes; or

would qualify for hedging treatment under certain accounting principles.

A swap would not be considered to hedge or mitigate commercial risk if that swap is used:

to speculate, invest or trade; or

to hedge or mitigate the risk of another swap (unless that other swap is used to hedge or mitigate commercial risk).

Regulating Uncleared Swaps

Uncleared swaps also will become subject to extensive new regulation, including comprehensive reporting and recordkeeping. Dodd-Frank requires the CFTC to adopt initial and variation margin requirements on uncleared swaps for swap dealers and major swap participants. In a Senate floor colloquy, Sen. Chris Dodd (D-CT and chairman of Senate Banking Committee) and former Sen. Blanche Lincoln (D-AR and chairman of Senate Agricultural Committee) stated that Congress intended the regulators to impose margin requirements only on swap dealers and major swap participants, not on end-users who qualify for the exemption from mandatory clearing.4 However, some members of the CFTC have questioned whether these margin requirements should be applied to end-users too.

Position Limits

If the CFTC determines position limits are necessary or appropriate for energy swaps and futures, Dodd-Frank requires the CFTC to establish position limits: (i) by instrument (i.e., on energy futures, options and swaps separately) and (ii) by commodity (i.e., on the aggregate number of futures, options and swaps per energy commodity). While many believed Dodd-Frank mandates that the CFTC adopt these limits by January 17, 2011, it is very unlikely limits will be imposed by that date as the CFTC has yet to publish proposed rules in this area.

Whistleblowers

Dodd-Frank encourages whistleblowers to provide information about potential violations of commodities law to the CFTC by offering protection against retaliation and substantial monetary incentives (up to 30 percent of monetary sanctions imposed in the resulting action). The CFTC has proposed and will adopt rules governing the procedures through which potential whistleblowers may submit information and apply for award payments.

EPA Regulatory Developments

The electric power industry is facing a plethora of air, water and solid waste regulations that will impose significant retrofit requirements on existing generating units. These regulatory developments include the following:

Clean Air Act

Hazardous Air Pollutants. In accordance with a consent decree entered in April 2010, the EPA is committed to proposing regulations limiting emissions of hazardous air pollutants (HAPs) from coal- and oil-fired electrical generating units that are major sources of HAPs by March 16, 2011, and finalizing such regulations by November 16, 2011. The emissions standards must be designed to achieve the maximum degree of emission reduction that the EPA determines is achievable for the affected units, taking into account costs and non-air quality environmental and health benefits (MACT). Unlike the Clean Air Mercury Rule that was vacated in 2008, the EPA must regulate all of the hazardous air pollutants emitted by these generating units. Based on the proposed industrial boiler MACT rule, it is anticipated that the EPA will propose MACT limitations for mercury, particulate matter (as a surrogate for nonmercury metallic HAPs), hydrogen chloride (surrogate for acid gas HAPs), carbon monoxide (surrogate for nondioxin organic HAPs) and dioxin/furans. Compliance with the MACT standards will be required three years after the effective date of the final regulation.

Clean Air Transport Rule. In July 2010, the EPA proposed the Clean Air Transport Rule (CATR) as a replacement for the Clean Air Interstate Rule, which was vacated in 2008 but later remanded to the EPA. The EPA anticipates finalizing this regulation in mid-2011. The purpose of CATR is to limit the interstate transport of sulfur dioxide and nitrogen oxide emissions that interfere with attainment or maintenance of the 1997 ozone national ambient air quality standard (NAAQS) and the 1997 annual and 2006 24-hour fine particulate matter NAAQS in downwind states. Thirty-one states in the East, South and Midwest will be required to comply with state budgets for sulfur dioxide and annual nitrogen oxide emissions (to address interference with the fine particulate matter standards) and/or ozone season nitrogen oxide emissions (to address interference with the ozone standard). The EPA has proposed three alternative rules: (i) the preferred alternative, which would allow intrastate emissions trading and limited interstate emissions trading; (ii) a second alternative that would allow only intrastate emissions trading; and (iii) an alternative that would not allow emissions trading, but would allow system averaging for commonly owned or operated emission units located within a state. Phase I of CATR goes into effect in 2012, and Phase II of CATR (reducing sulfur dioxide emission budgets in 15 states) becomes effective in 2014.

On a related note, the EPA has proposed a revision to the eight-hour primary ozone NAAQS and also will promulgate a secondary ozone standard to protect sensitive vegetation and ecosystems. The EPA had intended to finalize the revision to the eight-hour ozone NAAQS by December 2010, but on December 8, the EPA filed a motion requesting an extension until July 2011. It is expected that once the EPA finalizes the revised ozone NAAQS, it will propose a second Clean Air Transport Rule that may further impact electric power generating units. The EPA also intends to propose revised fine particulate matter NAAQS in 2011, which could result in further emission reduction requirements in future years.

Clean Water Act

Cooling Water Intake Structures. Section316(b) of the Clean Water Act requires the EPA to ensure that the location, design, construction and capacity of cooling water intake structures (CWIS) reflect the best technology available (BTA) for minimizing adverse environmental impacts. Although the EPA recently stated that it intended to propose a Section 316(b) regulation covering all existing electrical generation units and manufacturing facilities in 2011 and to finalize this regulation by July 2012, there have been reports that it intends to enter into a consent order with environmental groups that may extend those deadlines. Significant issues in this rulemaking will include the extent to which facilities will be required to replace once-through cooling water systems with closed-loop cooling systems and the extent to which the EPA will authorize site-specific variances based on cost/benefit analysis.

Effluent Limitations Guidelines. The EPA also has begun work on revising its technology-based limitations for pollutant discharges from steam electrical generating units, last revised in 1982. The updated regulations are expected to address, among other things, wastewater pollutants arising from the operation of ash ponds and flue gas desulfurization air pollution controls, the use of which are expected to expand as a result of the air pollution control regulations discussed above. In November 2010, the EPA entered into a consent decree with the Sierra Club and Defenders of Wildlife that requires the EPA to propose regulations by July 2012 and complete action on the regulations by January 2014.

Resource Conservation and Recovery Act

Coal Combustion Residuals. In May 2010, the EPA issued a proposal to regulate coal combustion residuals (CCR) generated by the combustion of coal at electrical generating facilities. We anticipate that the EPA will issue final regulations in 2011. The EPA proposed two alternatives. Under either proposal, most beneficial reuse of CCR would continue to be exempt from regulation, although the use of CCR as fill in operations such as sand and gravel pits and quarries would not be considered beneficial reuse.

Under one alternative, CCR would be regulated as “special wastes” that would, with certain modifications, subject the storage, transport, treatment and disposal of such wastes to hazardous waste regulation. Such regulations generally would subject existing treatment and disposal units, such as landfills and surface impoundments, to the applicable hazardous waste technical standards for such units, including liner, leachate collection and location requirements. It is likely that surface impoundments handling “wet” CCR would not be retrofitted and would therefore need to be closed no later than five years after the effective date of the regulation.

Under the other alternative, CCR would continue to be exempt from hazardous waste regulation but would be subject to minimum criteria governing its disposal. The technical standards under this alternative (the “Subtitle D” option) would be similar to the first alternative (the “Subtitle C” alternative), but there would be a few significant differences, including that existing landfills would not be required to be retrofitted to meet the liner/leachate collection standards (although groundwater monitoring would be required). Existing surface impoundments would need to be retrofitted to meet the standards, although the EPA also requested comment on an alternative that would allow existing surface impoundments to operate for the remainder of their useful life.

Health Care: Politics Will Dominate Media Coverage but Is Unlikely To Alter Near-Term Business Trends

The Debate Over Health Care Reform

The contentiousness of 2010’s health care reform effort appears headed for an encore in 2011. Although the Patient Protection and Affordable Care Act (PPACA) is officially in the books and various provisions are slated to come into effect in 2011, debates about the legislation’s sustainability, fairness and even legality show no signs of slowing. Two potentially conflicting efforts will play out in the coming year: As the administration attempts to push through rulemaking to implement PPACA, some members of Congress and state attorneys general will continue efforts to block portions of the legislation from taking effect. In many ways, 2011 will be the year in which the business community finds out whether reform floats or sinks.

Some PPACA provisions will go into effect in 2011 for the first time. For example:

The market-share-based fees on pharmaceutical manufacturers will begin, with the sector paying $2.5 billion in 2011.

Manufacturers of brand-name drugs will begin providing a discount for drugs in the Part D coverage gap. The federal government will begin providing a discount for generic drugs in the gap.

The biggest single year for federal anti-fraud funding under PPACA will be 2011, with the $10 million annual allocation being supplemented with a one-time-only $95 million.

When the medical-loss ratio for plans in the large group market reaches 85 percent (or 80 percent for plans in the small group and individual markets), these plans must provide rebates. This obligation extends to plans that are otherwise granted “grandfathering” protection from some other requirements; however, self-insurance plans are not affected by this requirement.

Employers will be required to include the value of employee insurance benefits on W-2s, though the administration has indicated it would work with Congress to repeal or modify this requirement.

Taxes on personal savings accounts will increase. The tax on health savings account and Archer medical savings account distributions not used for qualified medical expenses will rise to 20 percent. Over-the-counter drug purchases from health reimbursement arrangements and health flexible savings accounts will not be allowed, and such purchases from health savings accounts and Archer medical savings accounts will be taxed.

Several cost-cutting reforms will begin. The Centers for Medicare and Medicaid Services and Center for Medicare and Medicaid Innovation will be established to test payment reforms to Medicare, Medicaid and the Children’s Health Insurance Program that reduce costs and preserve quality. Medicare Advantage payments will freeze. Also, the Department of Health and Human Services (HHS) will report to Congress on how to move home health and nursing home providers into a value-based purchasing payment system, and a five-year grant program designed to encourage states to implement medical malpractice litigation alternatives will begin.

Medicare beneficiaries will be entitled to a free annual wellness visit and will not be asked to participate in cost-sharing for preventive services.

The federal government will provide $11 billion over five years, starting this year, for community health centers.

While outright repeal of PPACA is highly unlikely, repeal or modification of certain provisions may be more realistic. The list of targets includes the mandate for individuals to purchase insurance, the Independent Payment Advisory Board that will attempt to control Medicare spending and the tax on high-end insurance. One provision likely to change is the requirement that employers issue 1099 statements to anyone with whom they do more than $600 in business. The president has said this provision is too burdensome and that he is open to changing it.

PPACA foes have other options to use against the legislation. They could vote to withhold funding for various provisions (as was done successfully during the lame-duck session of the 111th Congress during consideration of the continuing resolution), an option that may gain traction in a deficit-wary political climate but which may risk a government shutdown. The House also is likely to use its oversight authority to slow down or block the promulgation of regulations.

Finally, state attorneys general will continue their efforts to challenge the legality of some of the law’s provisions. With early district court successes in Virginia and Florida, and the administration vowing aggressive appeals, the issue is all but certain to end at the Supreme Court.

Reform or Not — Enforcement Will Take Center Stage

While the political parties disagree on many health policy matters, one area has broad bipartisan support: tougher enforcement of laws combating health care fraud and abuse. Within the past two years, Congress has passed two major packages of tougher health care fraud laws, with increased penalties, new compliance and overpayment requirements, and increased resources for prosecutors and investigative agencies.

More troubling than the overall increase in enforcement scrutiny is the government’s more aggressive targeting of individuals — particularly executives — for prosecution and enforcement action. Within the past 12 months, prosecutors have charged several senior business executives and an in-house lawyer with health care fraud-related offenses, reflecting a policy decision within the federal law enforcement community to hold individuals accountable for corporate malfeasance. Prosecution, however, is not the only area of increased enforcement activity. The HHS Office of Inspector General has followed through on its threat to use its exclusion authorities more aggressively, forcing a foreign-based medical device company to divest its U.S. operating company (with more than 100 employees) following a guilty plea and, in a separate case, excluding a former pharmaceutical company CEO following the company’s guilty plea to manufacturing-related violations of the Food, Drug and Cosmetic Act. Every indication is that the recent uptick in the prosecution and exclusion of individuals is not an aberration but rather a policy decision that is not likely to be reversed in the near term.

Politics Won’t Alter Near-Term Trends for Health Care Companies

Last year, we predicted that health care reform would create winners and losers through (i) changes in health care business models, (ii) new taxes and fees, and (iii) changes in how hundreds of billions of dollars are spent by federal and state governments. We also predicted that one of the basic policy tradeoffs in the health care reform law — expanded coverage for tens of millions of Americans which would increase overall health care expenditures but compress margins by reduced reimbursement rates and increased costs — would lead to sector consolidation as companies seek profitability through economies of scale. For the most part, these predictions have come true.

Merger activity in the health care sector has been relatively strong, with more than 10 deals exceeding $1 billion in 2010. Sectors with comparatively robust M&A activity include hospitals and health systems, pharmaceutical manufacturers, medical device makers and health insurance companies (see “Global M&A”).We believe the drivers of this activity — particularly the legislative changes in the health care reform legislation and the continued low cost of debt and financing options — will persist through 2011.

In addition to M&A activity across the health care sector generally, we believe large pharmaceutical and medical device manufacturers will seek to bolster product pipelines and offset patent expirations through aggressive pursuit of in-licensing activities in the U.S. markets and expanded operations in foreign markets, where sales growth can exceed 20 percent or more in some major markets. Companies with specialty products that address serious health conditions (e.g., oncology, HIV/AIDS, asthma) and have superior clinical effectiveness data will be highly valued, particularly those without near-term generic competition (e.g., biotechnology products), while primary care products with lower-cost competitors will continue to face serious pricing pressures. Companies with significant exposure to Medicaid may experience headwinds, as significant new Medicaid spending by the federal government called for in PPACA may be offset by belt-tightening and budget cuts by cash-strapped state governments.

Health care providers will face many of the same pressures as pharmaceutical and device manufacturers. Consolidation will continue as companies seek profitability by expanding volume to offset reductions in reimbursement rates. Also, larger companies are in a better position to address the health care reform law’s new requirements relating to health IT, patient safety, and quality monitoring and reporting. As with manufacturers, providers with significant exposure to Medicaid will encounter challenges due to government budget pressures.

Privacy: On the Road to Comprehensive Privacy Legislation?

Over the past decade, there has been considerable debate over whether the United States ever would enact the type of omnibus data privacy legislation that exists in the EU member states and certain other countries. While data privacy laws have been enacted in the U.S. to protect certain types of personal information — such as health information or data held by financial services companies — most felt that omnibus federal data privacy legislation would result only if there was a significant new technological development that reshaped the manner in which Americans viewed their personal information. While such legislation still has not been enacted, the U.S. appears to be closer than ever to adopting such an approach.

Interestingly, the catalyst for this legislative activity has not been any single new technology or any new approach to collecting and mining data. Rather, over the past 24 months a steady drumbeat of new developments and disclosures of existing data practices has caused Americans to question how they want their personal information being used and their online activities being tracked. A consensus also is emerging that technology developments have far outpaced existing privacy protections, exposing Americans to unwanted uses of their personal information. As an example, traditional distinctions between personally identifiable information (such as name and address) and “anonymous” information are eroded when companies can use techniques such as browser “fingerprinting” or a mobile device’s Unique Device Identifier to build robust data profiles about an individual without actually learning the individual’s name.

The difficulty faced by many consumers, as well as U.S. legislators and regulators, is that expansive uses of personal information offer certain benefits (such as targeted advertising or personalized content) that consumers appreciate in certain circumstances but find overly invasive in other situations. Moreover, through services like Facebook, Twitter and Foursquare, an unprecedented number of people are voluntarily disclosing their personal information, suggesting to some that individuals are becoming less concerned about how their information might be used. Others feel, however, that most people do not fully appreciate how their information and Internet activity is being collected, tracked and stored.

There is a similar tension with respect to whether increased data privacy regulation will impede or fuel the burgeoning online advertising industry. Some argue that any new laws or regulations could have a detrimental impact on this multibillion-dollar business, a result that no lawmaker wants to be associated with in a weakened economy. Others argue that increased regulation is actually necessary to grow the online sector, because consumers need a better sense of security when they transact online or adopt new technologies.

Despite these inherent tensions, momentum appears to be building slowly on a number of fronts toward enactment of broad-based data privacy legislation in the United States. At present, five main legislative or regulatory initiatives, each described below, are under way in the U.S.: a Federal Trade Commission preliminary staff report, a Department of Commerce green paper on privacy, two House bills on privacy and a newly created executive branch task force on privacy. Additionally, new privacy initiatives are not limited to the United States. In November 2010, the European Commission outlined its proposed strategy to strengthen data protection in the EU, which includes improving the transparency of privacy policies and giving consumers greater rights to have the information deleted when it is no longer required.

Proposed House Legislation

In May 2010, Reps. Rick Boucher (D-VA) and Cliff Stearns (R-FL) released a discussion draft of an omnibus privacy bill.5 The bill would apply to any entity that collects personal information from more than 5,000 individuals in a 12-month period, either offline or online; such information would include “preference profiles” (i.e., a list of information or preferences associated with a specific individual or a computer/device). Before collecting, using or storing any personal information, a company must provide a clear and conspicuous privacy notice that includes, among other items, a description of the information collected, the purpose for which it is collected, and how individuals can exercise choice and access rights.

While opt-out consent would be permitted for many data uses, the bill would require opt-in consent for a number of common online practices including: (i) selling, sharing or otherwise disclosing personal information to unaffiliated parties; (ii) collecting or disclosing sensitive information (such as health information); (iii) collecting or disclosing personal information about all or substantially all of an individual’s online activity, including across websites; (iv) using information for a purpose different than that for which it was disclosed; and (v) using location-based information.

The FTC would be responsible for implementing and enforcing the legislation, and states also would have the right to enforce the FTC’s rules through state attorneys general or consumer protection agencies.

In July 2010, Rep. Bobby Rush (D-IL) introduced the Building Effective Strategies to Promote Responsibility Accountability Choice Transparency Innovation Consumer Expectations and Safeguards (“Best Practices”) Act. The Best Practices Act includes many of the same concepts as the Boucher/Stearns discussion draft, with the following key differences. The Best Practices Act:

provides the FTC with considerably more discretion to craft appropriate privacy regulations;

covers a broader range of “fair information practice principles” than the Boucher/Stearns draft;

permits individuals to bring certain civil actions, while the Boucher/Stearns draft contains no such right; and

provides that companies participating in FTC-approved self-regulatory programs are in a “safe harbor” and are not subject to the act’s opt-in consent requirements, access requirements or private right of action provisions.

As a general matter, the Best Practices Act has received greater support than the Boucher-Stearns draft from both privacy advocates and businesses. Privacy advocates have been pleased with the proposed act’s greater protection of personal information, while businesses are supportive of the “safe harbor” approach. Although other federal privacy legislation has been proposed in the past, the Best Practices Act addresses many of the concerns of the privacy community and comes at a time when there is an increased focus on privacy legislation. In addition, given that privacy protection is enjoying broad bipartisan support, there is an increased likelihood of such legislation being enacted.

On December 1, 2010, the FTC issued its long-awaited preliminary staff report on Protecting Consumer Privacy in an Era of Rapid Change. The report first describes the FTC’s long history of regulating privacy in the United States. (Indeed, the accompanying press release notes that the FTC has been “the nation’s chief privacy policy and enforcement agency for 40 years.”) The report then proposes a framework “to inform policymakers as they develop solutions, policies, and potential laws governing privacy, and to guide and motivate industry as it develops and refines best practices and self-regulatory guidelines.”

As part of this proposed framework, the FTC first notes the limitations of the “notice-and-choice” model, in which consumers are informed about a company’s privacy policies through a privacy notice and then have the choice either not to provide their data or, in some cases, to “opt out” of their data being used. According to the FTC staff report, privacy policies have become increasingly complex and fail to spell out the choices for consumers. Significantly, the FTC also recognizes that the harm to consumers from misuse of their personal information extends beyond traditional physical or economic injury. Rather, given today’s technology, the potential harm includes reputational harm, fear of being monitored and simply “having private information ‘out there.’”

The FTC framework includes four basic principles:

Scope. The framework applies to all commercial entities collecting or using consumer data that can be reasonably linked to a specific consumer, computer or other device. The key to this principle is the FTC’s inclusion of computers and devices, thereby addressing the fact that “anonymous” information linked to a device also can invade an individual’s privacy.

Privacy by design. The “privacy by design” concept states that companies should promote consumer privacy and incorporate privacy protection into their product and service development cycles. In addition, companies should limit the data they collect to what is necessary to provide the products or services being offered and delete data when it no longer is required.

Simplified choice. The FTC is concerned that consumers do not realize the choice they have regarding how their data is used because: (i) They typically are informed of this choice only once, and (ii) such notice often is relegated to a dense privacy policy that few people read. The FTC therefore recommends that consumers be offered the choice “at a time and in a context” when their data is going to be used. So that such choice options do not become overly intrusive, the FTC also suggests that choice not be required for commonly accepted practices, such as product fulfillment.

The most important FTC pronouncement with respect to choice relates to behavioral advertising (i.e., the display of ads based on a consumer’s browsing habits). The FTC notes that while some companies participate in self-regulatory systems that allow consumers to opt out of behavioral advertising, industry efforts have, in the view of the FTC, fallen short. The FTC therefore has supported the implementation of a “Do Not Track” mechanism; namely, a cookie or other technology that would signal to companies that the user does not want to be tracked. This mechanism could be put in place by legislation or possibly by “robust, enforceable self-regulation.”

Greater transparency. The transparency principle is the core of the FTC staff report and includes four subprinciples:

The FTC advocates the use of clearer, shorter and more standardized privacy policies so a consumer can more easily compare the privacy practices of different entities. It should be noted that while such standardization may seem reasonable, many financial institutions have been frustrated with the form model privacy notices that were introduced this year under Gramm-Leach Bliley (GLB). The experience under GLB suggests that a “one-size-fits-all” approach may not work for privacy protection.

Companies should provide consumers with reasonable access to their data, a principle that already exists in the EU and is required today of companies participating in the U.S.-EU Safe Harbor framework.

Companies must provide prominent disclosures and obtain affirmative (i.e., “opt-in”) consent before using personal data in a “materially different manner” than was claimed when the data was collected.

All “stakeholders” should expand their efforts to educate consumers about commercial data privacy practices.

Perhaps most importantly for companies, the FTC indicates that until comprehensive privacy legislation is enacted, it will “continue its vigorous law enforcement of the privacy area” under Section 5 of the FTC Act and other privacy laws it enforces. While some privacy advocates question whether the FTC has truly engaged in “vigorous enforcement” over the past few years, the issuance of the staff report and the FTC’s activities in certain privacy cases suggest that the FTC may indeed be adopting a more proactive role in the privacy sphere.

The report is replete with questions for the industry regarding how different matters should be addressed, and public comments on the report are being accepted until January 31, 2011. Any company that uses or processes personal information, or that builds profiles from anonymous data, should take advantage of this public comment period.

The Department of Commerce Green Paper

On December 16, 2010, just two weeks after the FTC staff report was released, the Department of Commerce (DOC) Internet Policy Task Force released its own green paper, setting forth the department’s views on data privacy. The green paper does not advocate any specific policy proposal. Rather, it sets forth possible approaches and invites further discussion in the domestic and global policy communities. Overall, the DOC advocates a self-regulatory framework, but with regulatory authorities stepping in if self-regulation falls short.

The centerpiece of the green paper is a “Dynamic Privacy Framework,” which consists of policy recommendations in four categories:

Revitalized Fair Information Practice Principles. The DOC notes that many Internet users misunderstand commercial data privacy protections, and therefore recommends that the U.S. government recognize Fair Information Practice Principles. These principles should emphasize substantive privacy protection “rather than simply creating procedural hurdles,” and they should include the promotion of clear and simple privacy notices and commitments to limit data to fulfill stated purposes. Significantly, the DOC notes that possible approaches include “voluntary, enforceable codes of conduct”; safe harbors against FTC enforcement for complying with these codes; and disfavoring “prescriptive rules.”

Voluntary privacy codes and the creation of a Privacy Policy Office. The DOC advocates multistakeholder bodies in which commercial and noncommercial actors voluntarily participate to create voluntary codes of conduct that promote informed consent and safeguard personal information. Regulatory authorities would step in if these bodies did not create meaningful data practices. In order for the government to coordinate these efforts, the DOC recommends the creation of a Privacy Policy Office (within the DOC).

Global interoperability. The DOC notes that disparate global privacy laws have an adverse impact on global competition and recommends that the U.S. take a leadership role in the global privacy policy debate. This includes establishing that the U.S. has a strong privacy framework that it is committed to strengthening. The DOC also acknowledges the burden that many companies face in satisfying EU requirements for transborder data flow to the United States. However, the DOC appears to advocate an acceptance by the EU of a self-regulatory framework in the U.S., rather than the enactment of omnibus data privacy legislation.

National security breach notification rules. Today, almost every state requires notification to affected consumers in the event a company suffers a data security breach. Any company that has provided such notice is well aware of the many differences that exist in these laws from state to state. The DOC therefore recommends the creation of a unified breach notification rule that would harmonize these various state requirements and would be enforced by state authorities and the FTC.

The green paper marks just the first step in the DOC’s analysis of these issues. The DOC has invited comments and input as it works toward the creation of its final white paper on this topic.

Obama Administration Task Force on Privacy

In October 2010, a new White House Subcommittee on Privacy and Internet Policy was formed with the mandate of working with the DOC and FTC on Internet policy and privacy issues. The subcommittee, which is part of the White House’s National Science and Technology Council’s Committee on Technology, is being co-chaired by Cameron Kerry, general counsel at the DOC, and Christopher Schroeder, assistant attorney general at the U.S. Department of Justice. Other agencies represented on the subcommittee include the departments of Education, Energy, Health and Human Services, Homeland Security, State, Transportation and Treasury.

The subcommittee’s charter states that its mission is to “develop strategic direction on information privacy policy that can guide legislative, regulatory and international policy consensus.” Currently, the subcommittee is focused on three main deliverables:

an “Administration White Paper on Information Privacy in the Internet Age” that builds on the work of the FTC and DOC and examines the development of new privacy protection tools as well as cloud-computing issues;

development of Internet policy principles that will focus on a variety of issues, including cybersecurity and intellectual property enforcement; and

coordination of the administration’s statements on privacy and Internet policy.

* * *

At present, no major operational changes are required by companies to respond to the flurry of activity surrounding the privacy debate. However, companies should be cognizant that privacy, and particularly online data privacy, is receiving an unprecedented amount of attention and, potentially, regulatory enforcement. Companies are well advised to audit their privacy practices to ensure that they are consistent with their stated privacy policies. In addition, companies should carefully consider whether any data use or mining they are conducting, while technically permissible, might create public relations or reputational issues if disclosed. Finally, companies should closely monitor legislative and regulatory developments in this area in 2011.

On August 10, 2010, President Obama signed into law the Education Jobs and Medicaid Assistance Act of 2010, which contains several provisions (two of which are discussed here) that will impose higher taxes when U.S.-based multinationals access their foreign earnings. Because the United States taxes a U.S. corporation’s worldwide income, a taxpayer may credit foreign taxes against its U.S. tax liability to ensure that the same income is not taxed twice, once by the non-U.S. jurisdiction where it is earned and again by the United States. The new provisions, generally effective beginning in 2011, defer or permanently disallow foreign tax credits that otherwise would be available to the U.S. multinational, either when it earns the income directly through a branch or when it brings back foreign earnings from a subsidiary through a dividend or loan.

The increased tax costs on foreign earnings will further exacerbate the competitive disadvantage U.S. corporations face. As a result, these changes may cause some U.S. corporations to reassess the carrying costs of noncore operations. Because many non-U.S. entities are subject to a significantly lower tax burden, they may bring extra tax efficiencies to bear once they acquire a U.S. corporation’s non-U.S. business. For example, many non-U.S. entities would not be subject to tax in their home jurisdiction when they withdraw earnings from another country, thus allowing them to move earnings more easily within their tax structure.

‘Hopscotch Loans’

When a U.S. taxpayer borrows from a foreign subsidiary, it generally is deemed to have received a taxable dividend directly from the lending subsidiary, and the U.S. borrower is able to credit a portion of the foreign taxes paid by the foreign lending subsidiary against its U.S. tax liability for the deemed dividend. These deemed dividends and foreign tax credits are said to “hopscotch” over any subsidiaries between the lending foreign subsidiary and the ultimate U.S. shareholder. Under prior law, where the foreign lending subsidiary paid a high tax rate in its local jurisdiction, there may have been little or no residual U.S. tax due upon the loan, notwithstanding that the high-taxed foreign subsidiary was owned indirectly through a low-taxed foreign subsidiary (for example, a holding company in a low-tax jurisdiction).

New Anti-Hopscotch Provision

New Section 960(c), effective for loans (and certain other acquisitions of “United States property” by foreign subsidiaries) made after December 31, 2010, limits the amount of foreign tax credit that is available when a foreign subsidiary lends earnings to its indirect U.S. shareholder. The new provision will limit the amount of foreign tax credits available to the lesser of the amount determined under prior law or the amount that would be available if the foreign subsidiary instead actually had distributed a dividend through the chain of ownership to its indirect U.S. shareholder; generally this will dilute the amount of foreign tax credits available when a high-taxed foreign subsidiary is owned by a low-taxed subsidiary (a common tax structure).

Basis Step-Up Transactions

U.S. taxpayers may achieve a “step up” in the basis of non-U.S. assets for U.S. tax purposes by making a special election in connection with certain acquisitions of stock of a corporation or of a partnership interest, or by acquiring equity in an entity that is disregarded for U.S. tax purposes (which is viewed as a direct asset purchase for such purposes). Amortization or depreciation deductions with respect to the increased tax basis result in a difference between the foreign income upon which foreign tax is levied and the U.S. income upon which U.S. tax is levied and with respect to which a foreign tax credit may be allowed. In other words, a U.S. taxpayer may include an amount of foreign income that has been reduced by depreciation deductions for U.S. tax purposes while it credits an amount of foreign taxes that have been imposed on a comparatively greater amount of income for non-U.S. tax purposes.

Foreign Tax Credits Attributable to Basis Differences Disallowed

New Section 901(m) disallows a portion of foreign tax credits attributable to a “covered asset acquisition” occurring after December 31, 2010. For this purpose, “covered asset acquisition” corresponds to the type of basis step-up transaction described above. A portion of foreign tax credits will be disallowed based on a ratio of (i) the aggregate basis differences under U.S. and foreign tax law, and (ii) the income on which foreign tax is levied (determined under local law).

Going Forward

U.S. multinationals should revisit their existing organizational structures and tax-planning strategies in light of these (and other) new changes to determine whether structural or operational changes are warranted. In addition, these higher tax costs may lead U.S. multinationals to reconsider the “carrying cost” of noncore operations abroad. A strategic non-U.S. buyer, operating in a lower-tax jurisdiction, may value a U.S. corporation’s non-U.S. operations more than the U.S. corporation does and may be willing to pay a premium for such operations.

White Collar Crime

As 2010 came to a close, Lanny Breuer addressed what every white collar lawyer wanted to know heading into a new year — “emerging enforcement trends” from the DOJ’s perspective. Breuer, who serves as assistant attorney general for the Criminal Division, underscored “the reinvigoration of the DOJ’s criminal enforcement program” by highlighting the addition of more than 30 new prosecutors in the DOJ’s Fraud Section, increased reliance on “undercover investigative techniques,” and enhanced and “on the rise” Foreign Corrupt Practices Act (FCPA) enforcement. The message was clear: the DOJ has “stepped up [its] white collar investigations and prosecutions in the last year and a half,” and that trend will continue in 2011.6

The DOJ’s message for the new year, which undoubtedly is responsive to calls for a more proactive approach to investigating and prosecuting financial crime, paints this picture of the 2011 white collar law enforcement agenda:

Insider trading. Federal prosecutors will continue their aggressive pursuit of insider trading. U.S. Attorney for the Southern District of New York Preet Bharara, who brought the pending and highly visible case against Galleon Group founder Raj Rajaratnam, recently stated that “insider trading is rampant and may even be on the rise,” and thus is his “top criminal priority.”7 The Galleon investigation alone reportedly has resulted in 23 arrests and 14 guilty pleas, in addition to sparking vibrant debate about the DOJ’s use of wiretaps in white collar cases. The end of the year saw new headlines of insider trading arrests, and we anticipate no reversal of the trend in 2011.

Investment and mortgage fraud. In December 2010, Attorney General Eric Holder minced no words in stating that “financial fraud crimes have reached crisis proportions,” and that the DOJ, as a member of President Obama’s Financial Fraud Enforcement Task Force, will remain focused on the full gamut of financial fraud, especially investment and mortgage schemes.8 The icon from last year is the DOJ’s prosecution of former Taylor, Bean & Whitaker Mortgage Corporation Chairman Lee Bentley Farkas for bank and mortgage fraud that allegedly resulted in losses of more than $1.9 billion. The Farkas prosecution entails allegations of TARP fraud, demonstrating continued law enforcement focus on cases connected to the credit crisis. Indeed, in his most recent report to Congress, the special inspector general for the Troubled Asset Relief Program revealed its participation in “130 ongoing criminal and civil investigations,” ranging from TARP fraud to false statement and obstruction of justice cases.9 We expect the past to be prologue in these areas.

Foreign corrupt practices. The DOJ is coming off a record year in FCPA enforcement, having collected “well over $1 billion” in penalties and marking what Lanny Breuer recently called “a new era of FCPA enforcement” that is “here to stay.”10 This news comes against the backdrop of the U.K. Parliament’s enactment earlier in 2010 of a landmark anti-bribery law with broad extraterritorial reach and strong provisions for corporate criminal liability. The new U.K. law becomes effective in April 2011, and in its wake, we expect to see even more investigative activity added to an already-busy anti-bribery law enforcement agenda.

Health care fraud. We fully expect health care fraud to remain an area of priority focus for the DOJ in 2011, including prosecutions and civil enforcement actions against corporate defendants and individual executives and managers (see “Health Care: Politics Will Dominate Media Coverage but Is Unlikely To Alter Near-Term Business Trends” above). Since 2007, the DOJ has charged more than 825 individuals with criminal health care fraud.11 On the civil enforcement side, the DOJ recovered more than $2.5 billion under the False Claims Act in health care cases, a 60 percent increase over the 2009 level.12 Last year alone, the DOJ opened more than 2,000 new criminal and civil cases.13 We see the trend toward more criminal and civil enforcement, including cases against companies and individuals, continuing into 2011.

With the DOJ’s agenda in clear view, two equally clear messages emerge for corporations and their officers and directors:

Review corporate policies. The beginning of the new year presents a good opportunity for companies to review carefully their insider trading policies and anti-corruption compliance programs. Our experience indicates that companies benefit from establishing top-shelf policies and programs, enforcing those measures through regular training, and otherwise promoting cultures of compliance — points emphasized in the DOJ’s Principles of Federal Prosecution of Business Organizations and strongly reinforced by the November 1, 2010, amendments to Federal Sentencing Guidelines for organizations.

Commit to swift investigations and complete remediation. The seemingly ubiquitous message from the DOJ is to encourage companies, upon learning of potential criminal conduct, to commit promptly to a thorough investigation and plan of remediation. The DOJ also places great emphasis on the self-reporting of criminal conduct — an issue not without great complexity in certain circumstances. The overarching point is to recognize the urgency of time when discovering potential criminal conduct and the immediate need for experienced counsel to help define and navigate a path forward, including with law enforcement — with whom the initial communications often prove the most important in an investigation.

This memorandum is provided by Skadden, Arps, Slate, Meagher & Flom LLP and its affiliates for educational and informational purposes only and is not intended and should not be construed as legal advice. This memorandum is considered advertising under applicable state laws.